Improving the Activation Level of Diabetic Individuals

NCT06973954 | Active Not Recruiting

• 1 other identifier: Dokuz EU- HSE-IMN Phd- GY-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the activation levels of diabetic individuals and to improve the activation level. The study, planned as a descriptive and experimental type, is an attempt to increase the activation level of diabetic individuals.

Conditions

Diabetes Mellitus (DM); Type 2 Diabetes Mellitus (T2DM); Patient Activation; Diabetes Self-management

Keywords

Diabetes Mellitus; Type 2 Diabetes Mellitus; Patient Activation; Patient Activation İnterventions; Improving Patient Activation

Outcome Measures

Primary Outcomes (2)

• Patient Activation Measure

  In the first stage of our research, planned as descriptive, the following questions were sought. In this stage, the Patient Activation Level Measurement Tool (PAM), socio-demographic and disease-related characteristics questionnaire, and the Multidimensional Diabetes Questionnaire were used to measure the activation level of diabetic individuals. Are the socio-demographic characteristics of diabetic individuals related to the activation level? Are the disease-related characteristics of diabetic individuals related to the activation level? Are the perceived obstacles, perceived severity, perceived self-efficacy, perceived support, perceived outcome expectations of diabetic individuals evaluated with the multidimensional diabetes questionnaire related to the activation level?

  6 months

• Patient Activation Level

  In the second experimental phase of the study, it is planned to increase the activation level of diabetic individuals with an intervention. The activation level of diabetic individuals is determined with the Patient Activation Level Measurement Tool (PAM). PAM is a valid, highly reliable, unidimensional, Guttman-type scale. It consists of 13 items. Activation is a four-stage process: 1. Believing in the importance of taking an active role, 2. Knowledge and confidence to take action, 3. Taking action, 4. Maintaining routine even under stress. Activation scores range from 0 to 100. Stage 1: lowest activation: 0-47, Stage 2: 47.1 - 55.1, Stage 3: 55.2 - 67.0, Stage 4: highest activation: 67.1-100 (Hibbard, et al, 2004).

  6 months

Secondary Outcomes (1)

• Self-care Behaviors, Metabolic Control Values, Self-Effectiveness Level

  6 months

Study Arms (2)

Experiment group (Message Sent)

ACTIVE COMPARATOR

The experimental group consisted of 30 diabetic individuals. As an intervention, it was planned to send short messages containing information about diabetes, created by the researcher, to the diabetic individuals in the experimental group. The short messages were planned to be sent 3 days a week for 8 weeks.

Other: Text Message Intervention

Control Group (Message not sent)

NO INTERVENTION

The control group consists of 30 diabetic individuals. No intervention will be applied to the control group.

Interventions

Text Message Intervention OTHER

This intervention was prepared by the researcher with the support of artificial intelligence to increase the activation of diabetic individuals in the experimental group. It consists of short messages with the themes of gain, loss and motivation related to diabetes and self-management.

Experiment group (Message Sent)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having diabetes for 1 year or more, Able to read and write Turkish, Having no visual, auditory, perceptual or any other physical disability, Having the physical, mental and emotional capacity to participate in self-care activities, Having no language problems, Accepting to participate voluntarily in the study.

You may not qualify if:

• Individuals with any mental/cognitive problems,
• Those who cannot read or write,
• Those with visual, hearing, perception or any physical disability,
• Those who are immobile or bedridden,
• Those who do not have the ability to participate in their own self-care activities,
• Those who do not want to participate in the study were excluded from the sample.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Health Sciences Institute Izmir

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Patient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dilek Büyükkaya Besen, Associate professor

  Dokuz Eylul University Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, PhD Student

Model Details: The study is a randomized controlled study planned in two stages: descriptive and experimental. In the first descriptive stage, variables related to the activation level of diabetic viruses were determined. Data were collected from 151 diabetic individuals. The second experimental planned stage was conducted on 30 individuals in the experimental group and 30 individuals in the control group, determined by randomization from 151 diabetic individuals whose data were collected in the first stage.

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 15, 2025
• Study Start: January 2, 2025
• Primary Completion: May 30, 2025
• Study Completion: August 25, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)